MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET NEOPT CS-2 ADH SENSOR; OXIMETER

Model Number	4474
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that "the spo2 values measured by the monitor are 'falsely' low compared with the clinical signs and blood gas results, and when compared with other pulse oximeters"."the delta observed could vary from 2 to 15 pts versus other pulse oximeters"."this has led to unnecessary oxygen treatment" with no patient impact reported.
Additional Manufacturer Narrative
Other, other text: the masimo representative has confirmed the sensor will not return to allow an analysis to be performed.If the sensor is returned for evaluation or new information is obtained, a follow up report will be submitted.Health effect impact code: no adverse event; no patient impact h3 other text: product not returned.

• Brand Name: RD SET NEOPT CS-2 ADH SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: rishi jain ; 15750 alton pkwy; irvine, CA 92618
• MDR Report Key: 24397390
• Report Number: 3019388613-2026-00052
• Device Sequence Number: 8253734
• Product Code: DQA
• UDI-Device Identifier: 10843997013304
• UDI-Public: (01)10843997013304(17)271101(10)24MW4
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4474
• Device Lot Number: 24MW4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN 100293.; PN 4474 LOT 25DX2, PN 4473.; PN 4551 LOT 25E69.
• Patient Sex: Unknown
• Patient Weight: 1 KG